The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Fetal Monitors, Models F2 And F3.
| Device ID | K102140 |
| 510k Number | K102140 |
| Device Name: | FETAL MONITORS, MODELS F2 AND F3 |
| Classification | System, Monitoring, Perinatal |
| Applicant | EDAN INSTRUMENTS, INC. NANHAI ROAD 1019#, SHEKOU, NANSHEN Shenzhen, Guangdong, CN |
| Contact | William Stern |
| Correspondent | William Stern EDAN INSTRUMENTS, INC. NANHAI ROAD 1019#, SHEKOU, NANSHEN Shenzhen, Guangdong, CN |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2011-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B632MDB01008 | K102140 | 000 |
| 00815871020299 | K102140 | 000 |